Swiss CDMO Lonza, which has run into FDA concerns about its FDA operations before, has had its cell therapy facility in the U.S. slapped with a warning letter.

Fresenius’ new CEO has pulled off a dealmaking double play, committing more than $5.4 billion to expand its reach in both sterile generics and in biosimilars.

French regulators have warned the European Medicines Agency (EMA) that a sterile manufacturing operation in Brazil has some significant problems and its…

Sun Pharma has had another setback in its manufacturing for the U.S. market with the FDA laying out nearly a dozen observations for a solid dose formulation…

The FDA issued Aurobindo Pharma a Form 483, citing six observations related to procedural improvements at the company’s Unit III facility at Bachupally in…

Swedish CDMO Recipharm’s growing global footprint in 2016 has positioned the company to take advantage of what is expected to be more consolidation and growth…

The FDA posted a document outlining the issues that have undermined AstraZeneca's efforts to win approval for ZS-9.

Fujifilm is investing about $130 million in its U.S. and U.K. plants to increase biologics manufacturing as it races to capture a piece of the growing business.

Cobra Biologics will inject $19 million into facilities located in the U.K. and Sweden to help the CDMO meet increased demand from gene and immunotherapy…

Manufacturing